Regeneron Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Regeneron Pharmaceuticals third quarter earnings conference call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star and 0. I would now like to hand the conference over to your speaker today, Justin Holko, Vice President of Investor Relations. Please go ahead.

Thank you, Didi. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the third quarter 2021 conference call. An archive of this webcast will be available on our website. Joining me today on the call are Dr. Leonard Schleifer, Founder, President, and Chief Executive Officer of Dr. George Yancopoulos, co-founder, president, and chief scientific officer, Marion McCourt, executive vice president and head of commercial, and Bob Landry, executive vice president and chief financial officer. After our prepared remarks, we will open the call for Q&A. I would also like to remind you that remarks made on today's call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission's including its Form 10-Q for the period ended September 30, 2021, which we filed with the SEC earlier today. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Lenschleifer.

Thank you, Justin. And before I begin my remarks, let me just note that this may be Justin's last call. It may not be, at least in the position of IR. He is making a transition. He's decided he wants to make the news, not just report and explain the news. And he is moving over to our commercial organization. So we're very excited, but we're not letting him go until his replacement is fully in place. So you may hear more from Justin in this role, but you may not. Justin has done a remarkable job. He's quick to point out to me that when he joined the company, the stock was only around 300 bucks, and now he says it's significantly higher. Justin, we thank you for your great service. Turning to our business, we turned in another strong performance in the third quarter, which was marked by significant double-digit top and bottom-line growth and continued operating leverage. This was all possible as a result of the truly exceptional execution by our colleagues across the entire company, from R&D to production, commercial, and support teams, despite the challenges that we all faced imposed by the COVID-19 pandemic. Our core business of ILEA, Dupixent, and Leptio all contributed solid underlying growth. Additionally, we secured a third supply agreement with the United States government for Regenco, our investigational antibody cocktail for treating and preventing COVID-19 in certain populations. with initial deliveries fueling additional growth momentum in the quarter. In R&D, our broad and growing pipeline, which now includes more than 30 clinical stage candidates, with many more expected to enter the clinic in short order, continues to advance new innovations to secure our long-term growth potential. Importantly, our pipeline continues to be largely composed and comprised of internal innovation But increasingly, it is supplemented by external relationships that bring in novel modalities, including CRISPR and siRNA, creating unique treatment options and combination approaches, as George will outline momentarily. In the third quarter, beginning with ILEA, global net sales of ILEA were 2.4 billion, growing 15% compared to the prior year. U.S. ILEA sales grew 12%, reflecting recovery of the anti-VEGF category and share gains as the leading anti-VEGF treatment for retinal diseases. We see the strength of ILEA, an opportunity for steady growth continuing despite potential upcoming competition, from which we currently do not see any disruptive or game-changing new entrance to the anti-VEGF space for treating retinal diseases. continues to be remarkable in delivering commercially and clinically across a wide spectrum of type 2 inflammatory diseases. In the third quarter, global net sales grew 55% to $1.7 billion. Growth contributions from inside and outside of the United States continue to improve operating leverage in our alliance with Sanofi. Moreover, we announced positive results from four Phase III registrational studies in recent months, one in very young children with atopic dermatitis and three in the potential new indications of eosinophilic esophagitis, prurigo nodularis, and chronic spontaneous urticaria. In October, the FDA expanded our asthma label to include children aged 6 to 11, a testament to not only the efficacy but also the safety in the chronic treatment of type 2 inflammatory disease. With several other disease opportunities in clinical development, such as COPD, the expansion possibilities are significant for this remarkable medicine that is already changing the lives of hundreds of thousands of patients. In oncology, Libtyo global net sales were $120 million and grew 24%. Despite the challenges imposed on the oncology market by COVID-19, we're working hard as the leader in cutaneous squamous cell carcinoma and progressing in our basal cell carcinoma and lung cancer launches. We are also preparing for a potential launch in 2022 in the much larger opportunity of libtio combined with chemotherapy in non-small cell lung cancer. RegenCOV continues to grow in importance with increased utilization in the treatment of COVID-19. The FDA has accepted under priority review our biologic license application for the treatment and prophylaxis of COVID-19 in certain patients. We are also on review to expand the emergency use authorization for RegenCOV in certain hospitalized patients and for pre-exposure prophylaxis. Outside of the United States, our antibody cocktail has received a full approval in Japan, is conditionally approved in Australia and the UK, and has emergency or temporary pandemic authorizations currently in place in more than 40 other countries. Regencov has the potential for a broad range of prevention and treatment applications, from pre-exposure prophylaxis, to treatment of infected hospitalized patients. Given the anticipation of new COVID infections over time, increased utilization of Regencov in appropriate cases, and the need for prophylaxis in immunocompromised individuals, we anticipate an ongoing role for Regencov. If global demand warrants, we have the capacity to produce between 4 to 5 million 1.2 gram doses in 2022, excluding any further supply contributions from Roche. To conclude, as we close out 2021, our growth momentum is strong, and our outlook for continued growth, fueled by the breadth and depth of our pipeline, is bright. Now, I will turn the call over to George.